07.17.18
Roche announced that the phase III CAPSTONE-2 study assessing the safety and efficacy of baloxavir marboxil in people at high risk of complications from the flu met the study's primary objective, and showed superior efficacy in the primary endpoint of time to improvement of influenza symptoms versus placebo.
Baloxavir marboxil also demonstrated superior efficacy compared to placebo and oseltamivir for important secondary endpoints, including reducing the time that the virus continued to be released (viral shedding) and reducing viral levels in the body. Furthermore, baloxavir marboxil significantly reduced the incidence of influenza-related complications compared to placebo. Baloxavir marboxil was well tolerated and no safety signals were identified. Full results from the CAPSTONE-2 study will be presented at upcoming medical meetings. Baloxavir marboxil was discovered and developed by Shionogi & Co., Ltd., and is sold in Japan under the trade name Xofluza®.
"Baloxavir marboxil is the first antiviral to show a clinically meaningful benefit in people who are most susceptible to complications from the flu, including older people and those living with certain medical conditions," said Sandra Horning, MD, Roche's chief medical officer and head of Global Product Development. "We plan to submit the results of this second positive phase III study for baloxavir marboxil to healthcare authorities, and look forward to discussing next steps since there are no current antiviral medicines approved to specifically treat this high-risk population."
Baloxavir marboxil has already demonstrated a clinically significant benefit over placebo in otherwise healthy people in the phase III CAPSTONE-1 study. The U.S. Food and Drug Administration (FDA) recently accepted a New Drug Application (NDA) and granted Priority Review to baloxavir marboxil as a single-dose, oral treatment for acute, uncomplicated influenza in people 12 years and older based on the CAPSTONE-1 study and the phase II study, and is expected to make a decision on approval by December 2018. If approved, baloxavir marboxil would be the first single-dose oral antiviral, and the first medicine with a novel proposed mechanism of action to treat the flu in nearly 20 years.
"Baloxavir marboxil is the first antiviral to show a clinically meaningful benefit in people who are most susceptible to complications from the flu, including older people and those living with certain medical conditions," said Sandra Horning, MD, Roche's chief medical officer and head of Global Product Development. "We plan to submit the results of this second positive phase III study for baloxavir marboxil to healthcare authorities, and look forward to discussing next steps since there are no current antiviral medicines approved to specifically treat this high-risk population."
Baloxavir marboxil has already demonstrated a clinically significant benefit over placebo in otherwise healthy people in the phase III CAPSTONE-1 study. The U.S. Food and Drug Administration (FDA) recently accepted a New Drug Application (NDA) and granted Priority Review to baloxavir marboxil as a single-dose, oral treatment for acute, uncomplicated influenza in people 12 years and older based on the CAPSTONE-1 study and the phase II study, and is expected to make a decision on approval by December 2018. If approved, baloxavir marboxil would be the first single-dose oral antiviral, and the first medicine with a novel proposed mechanism of action to treat the flu in nearly 20 years.